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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-723NAP
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problem Hyperglycemia (1905)
Event Date 05/30/2014
Event Type  malfunction  
Manufacturer Narrative
The insulin pump received with unresponsive buttons due to corroded keypad traces.No button error alarm noted by analysis.Analysis unable to perform displacement, rewind, basic occlusion, occlusion, prime, and excessive no delivery alarm tests due to unresponsive buttons.The insulin pump's motor was tested outside the device and passed.The insulin pump was received with a scratched lcd window, a cracked reservoir tube lip, and a missing end cap sticker.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.
 
Event Description
The customer reported via phone call that the insulin pump had a button error alarm.The insulin pump was exposed to magnetic field.The blood glucose at the time of the incident was 146 mg/dl.Troubleshooting was not able to resolve the issue.The device was returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
Type of Device
INSULIN INFUSION PUMP / SENSOR AUGMENTED
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key6729211
MDR Text Key80755049
Report Number3004209178-2017-59635
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 05/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-723NAP
Device Catalogue NumberMMT-723NAP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/30/2014
Initial Date FDA Received07/20/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age29 YR
Patient Weight68
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